About 15 years ago, a reporter at the Albuquerque Tribune discovered evidence that during the Cold War, the U.S. government carried out radiation experiments on U.S. citizens without their knowledge or consent, all under the shadow of classified research. When the story hit the newswires, the U.S. public was outraged. President Bill Clinton responded by establishing the Advisory Committee on Human Radiation Experiments (ACHRE), calling on it to review Washington's past actions and recommend steps that would prevent such heinous human experiments from ever taking place again.
The committee made their recommendations in a 1995 report; and although Clinton issued a memorandum two years later that included several ACHRE prescriptions, bureaucratic delays kept it from being properly approved before he left office. The Department of Health and Human Services finally published it as an interim proposal in the Federal Register in 2002, but it remains unapproved by the appropriate agencies and departments.
So while it seems crazy, it's true: Today, in a country that for the last eight years has been defined by questionable intelligence-gathering techniques and interrogation methods, the U.S. government is no more restricted in carrying out nonconsensual, classified research on human subjects than it was after World War II. Thus, it's time for the Obama administration to reexamine the guidelines for classified experimentation on human subjects and close any loopholes that would allow a person to be unknowingly subject to experimentation. In fact, a prohibition on waiving informed consent in classified human-subject experiments should be the centerpiece of any new legislation--the waiver of this right being perhaps the most offensive aspect of the Cold War research programs.
Currently, the 1991 Federal Policy for the Protection of Human Subjects is the binding regulation on human-subject research for 17 federal agencies including the military and the intelligence agencies. Although it outlines the guidelines for informed consent, it also states, "Unless otherwise required by law, department or agency heads may waive the applicability of some or all of the provisions of this policy." In other words, a person participating in an experiment must be informed and give his consent unless a high-level government official doesn't think it is necessary. Not surprisingly, this authority doesn't stop with the heads of agencies and departments. The president also has the power to waive or modify these provisions through a presidential directive, which he can issue at any time, refuse to make public, and do without any person's or body's approval.
Therefore, until a federal statute that secures the right of informed consent for anyone subjected to classified human experimentation is passed by the legislature and signed into law by the president, the U.S. government has the power to carry out research projects without his consent and without informing the participants of the dangers or future complications.
Is the United States carrying out human-subject research without consent right now? We don't know. But speculation about the future of research and experimentation doesn't inspire confidence. Jonathan Moreno, a biomedical expert and author of Undue Risk: Secret State Experiments on Humans, writes, "Among the next generation of weapons is one that may involve a different sort of radiation than that emitted by atomic fission: microwaves. Electromagnetic waves may be used to disrupt an enemy soldier's central nervous system, to cause epileptic seizures." Anyone who doubts that the U.S. military may be considering such research need only consult a 2006 navy directive that includes guidelines for waiving consent and suggests the potential for research involving "severe or unusual intrusion, either physical or psychological, on human subjects (such as consciousness-altering drugs or mind-control techniques)."
In order to overcome more than 50 years of failed reforms, new approaches to human subject protections for classified experiments need to be developed, and troubling questions need to be an answered. How could this have happened and happened for so long? As we reflect on potential research and consider the ongoing debate regarding torture, the power of the executive branch, and the future of U.S. security, the need for strong, legally binding regulations governing human-subject research is undeniable. It's time, with a new administration that condemns torture of any kind, to establish regulations governing all human-subject protections in classified experiments and to ensure that no person, regardless of position, can take away a person's right to consent.